NIHA-001 performance evaluation test

Multicenter, single-arm study to assess the performance of NIHA-001

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2032220262

Enrollment

215

Registered

2022-08-10

Start date

2022-09-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NYHA I, II, III or IV heart failure without the need to wear implantable electronic devices such as

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: "(1) Patients who have consented to participate in the clinical trial in writing (2) Patients aged 20 years or older at the time of consent acquisition (3) Patients who have been diagnosed with heart failure by the time consent is obtained and have been judged by a doctor to be NYHA I, II, III or IV at the time of screening. (4) Patients not having a cardiac pacemaker or an implantable electronic device for pacing such as implantable cardioverter-defibrillators when their consent is obtained, and not planing to have it during the clinical trial. However, patients who have implantable electronic device when their concent is obtained, but it does not work due to dead batteries etc. and who not plan to operate the device during the trial are eligible to enroll.

Exclusion criteria

Exclusion criteria: "(1) Patients after congenital heart disease or heart transplantation (2) Patients suffering from pulmonary hypertension not caused by heart failure at the time of obtaining consent (3) Dextrocardia patients (4) Patients participating in other clinical studies or clinical trials. However, this excludes observational studies that do not involve intervention with pharmaceutical products, etc. (5) Other patients who are judged to be ineligible by the investigator or sub investigator"

Design outcomes

Primary

Measure	Time frame
Sensitivity / specificity of NYHA classification (III or higher) by test device for each combined device to NYHA classification (II or lower / III or higher) by doctor	—

Secondary

Measure	Time frame
"Sensitivity, specificity, correct diagnosis rate, Kappa coefficient, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio of NYHA classification of test device for each combination device or subject background to NYHA classification(II or less / III or more) by doctors. We also consider subjects whose NYHA classification by physicians was difficult to determine, incorrect answers (false positives and false negatives), probabilities for each class, and HF-INDEX."	—

Measure

Time frame

"Sensitivity, specificity, correct diagnosis rate, Kappa coefficient, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio of NYHA classification of test device for each combination device or subject background to NYHA classification(II or less / III or more) by doctors. We also consider subjects whose NYHA classification by physicians was difficult to determine, incorrect answers (false positives and false negatives), probabilities for each class, and HF-INDEX."

—

Contacts

Public ContactMinoru Shiratsuchi

SIMPLEX QUANTUM, Inc.

system@simplex-q.com+81-3-6450-3600

Outcome results